This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Registration & Post-Approval Stage
Navigating pharmaceutical and biotechnology product registration and post-approval with expertise
We ensure compliance, optimize market access, and support sustained success for your product.
Our Key Services
- Regulatory strategy development to guide your drug through submission and approval
- Regulatory dossier preparation and response to Requests For Information (RFI)
- Global drug registration services, ensuring compliance with diverse regulatory bodies including the FDA and EMA
- Post-approval services, including pharmacovigilance, post-market surveillance, and ongoing regulatory compliance, and CMC changes
Why partner with VCLS?
- Comprehensive regulatory solutions from preclinical development to post-approval lifecycle management
- Global regulatory expertise
FAQs
Who is required to register and list?
The owner or operator of an establishment entering into the manufacture, preparation, propagation, compounding, or processing (which includes, among other things, repackaging and relabeling) of a drug or drugs must register the establishment with the FDA within 5 days after beginning the operation.
This includes all contract manufacturers involved in any step of the manufacturing supply chain.
read more
How is a change to an approved NDA/BLA/ANDA categorized?
Changes are categorized based on a series of evaluations regarding the change.
If multiple changes are related, the reporting category will be the most stringent of the cumulative changes. It is important to stress that the categorization is based on the change itself and not the outcome of the change.
read more
Related Glossary
LCM (Life Cycle Management)
Post-Market Surveillance
Labeling
Post-Approval Change Management Protocol (PACMP)
Scale-up and Post Approval Changes (SUPAC)
Amendment
Questions? Get the answers from our expert team
No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.